Phase 3
Completed N=95
A Study to Evaluate the Efficacy and Safety of Dasotraline in Children 6 to 12 Years Old With Attention-Deficit Hyperactivity Disorder (ADHD) in a Simulated Classroom Setting.
Source: ClinicalTrials.gov NCT03231800 ↗Enrolled (actual)
95
Serious AEs
0.0%
Results posted
Jun 2020
Primary outcomePrimary: Change From Baseline at Day 15 in , ADHD Symptoms as Measured by Mean Swanson,Kotkin,Agler,M-Flynn, Pelham Rating Scale(SKAMP)-Combined Score Obtained From an Average of the 7 Assessments Collected Across the 12-hour Classroom Day(12 to 24 Hours Postdose) — 1.57; -3.67 Units on a scale — p=<0.001
◆ Published Evidence
Emerging
7citations · ~2 / year
A Randomized, Placebo-Controlled Laboratory Classroom Study of the Efficacy and Safety of Dasotraline in Children With ADHD.
Summary
A study to evaluate the efficacy and safety of dasotraline in children 6 to 12 years of age with Attention-Deficit Hyperactivity Disorder (ADHD) in a simulated classroom setting.
Linked Publications
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A Randomized, Placebo-Controlled Laboratory Classroom Study of the Efficacy and Safety of Dasotraline in Children With ADHD.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline at Day 15 in , ADHD Symptoms as Measured by Mean Swanson,Kotkin,Agler,M-Flynn, Pelham Rating Scale(SKAMP)-Combined Score Obtained From an Average of the 7 Assessments Collected Across the 12-hour Classroom Day(12 to 24 Hours Postdose) |
1.57; -3.67 | <0.001 sig |
| SECONDARY Change From Baseline at Day 15 in Mean Swanson, Kotkin, Agler, M-Flynn, and Pelham Rating Scale (SKAMP)Attention Subscale Score Obtained From the 7 Assessments Collected Across the 12-hour Classroom Day (12 to 24 Hours Postdose) |
1.10; -0.27 | — |
| SECONDARY Change From Baseline at Day 15 in Mean Swanson, Kotkin, Agler, M-Flynn, and Pelham Rating Scale (SKAMP)-Deportment Subscale Score Obtained From the 7 Assessments Collected Across the 12-hour Classroom Day (12 to 24 Hours Postdose) |
0.50; -1.78 | — |
| SECONDARY Change From Baseline at Day 15 in Mean Permanent Product Measure of Performance (PERMP)-Attempted Problems Scores Obtained From the 7 Assessments Collected Over the 12-hour Classroom Day (12-24-hours Postdose) |
3.51; 17.37 | 0.016 sig |
| SECONDARY Change From Baseline at Day 15 in Mean Permanent Product Measure of Performance (PERMP)-Correct Problems Scores Obtained From the 7 Assessments Collected Over the 12-hour Classroom Day (12-24-hours Postdose) |
5.47; 17.53 | 0.031 sig |
Eligibility Criteria
Inclusion Criteria
- Subject is 6 - 12 years old, inclusive at screening and randomization.
- Subject weighs ≤ 30 kg at the time of screening.
- At least one of the subject's parents/legal guardians must give written informed consent, including privacy authorization, prior to study participation. The subject will provide informed assent prior to study participation.
- Subject meets Diagnostic and Statistical Manual of Mental Disorders Fifth Edition (DSM-5) criteria for a primary diagnosis of ADHD (inattentive, hyperactive, or combined presentation) at screening established by a comprehensive psychiatric evaluation that reviews DSM-5 criteria and confirmed using the Schedule for Affective Disorders and Schizophrenia for School-Age Children-Present and Lifetime version (K-SADS-PL) at screening.
- Subject is currently either untreated for ADHD or receiving a treatment regimen of a stimulant medication prescribed as monotherapy (i.e., methylphenidate, mixed amphetamine salts, lisdexamphetamine, or dextroamphetamine) within the approved labeled dose range for ADHD..
- In the opinion of the investigator, the subject is not treatment refractory.
- Any subject not receiving ADHD medication at screening must display clinically significant ADHD symptoms, as measured by an ADHD-RS-IV score ≥ 26 at screening and Day -7.
- For any subject receiving monotherapy stimulant treatment for ADHD, that treatment must be well tolerated and clinically effective based on clinical assessment and informant interview, as well as, review of available medical records. Note: The ADHD Rating Scale Version IV - Home Version (modified for investigator administration) (ADHD RS IV HV) will be administered at Screening by the investigator to inform clinical evaluation.
- Subject is male or a non-pregnant, non-lactating female.
- Subject, if female, must not be pregnant or breastfeeding, and if ≥ 8 years of age must have a negative serum pregnancy test at screening.
- Female subjects of childbearing potential and male subjects with female partners of childbearing potential must practice true abstinence (consistent with lifestyle) and must agree to remain abstinent or agree to use an effective and medically acceptable form of birth control, from the time of informed consent/assent to at least 14 days after the last dose of the study drug has been taken.
- Subject must be in general good health (defined as the absence of any clinically relevant abnormalities as determined by the investigator) based on screening physical and neurological examinations, medical history, and clinical laboratory values (hematology, chemistry, and urinalysis). Note: If any of the hematology, chemistry, or urinalysis results are not within the laboratory's reference range, then the subject can be included only if the investigator determines the deviations to be not clinically relevant.
- Subject is within the 3rd to 97th percentile for gender specific weight-for-age from the Centers for Disease Control and Prevention (CDC) growth charts
- Subject must report a history of being able to swallow capsules.
- Subject and subject's parent/legal guardian must be able to fully comprehend the informed consent/assent forms, understand and be willing and able to comply with all study procedures and visit schedule, and be able to communicate satisfactorily with the investigator and study coordinator.
- Subject, on Day -1, has evidence of clinically significant ADHD symptoms as measured by an ADHD RS IV HV total score ≥ 26. If subject has been receiving stimulant pharmacotherapy for ADHD the ADHD RS-IV should be administered following a minimum 72 hour washout from prior ADHD medication treatment.
Exclusion Criteria
- Subject or parent/legal guardian has commitments during the study that would interfere with attending study visits.
- Subject is currently being treated for ADHD with a non-stimulant product, or has been treated with a non-stimulant product in the 4 weeks pr
Data sourced from ClinicalTrials.gov (NCT03231800) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.